The treatment regimen comprises neoadjuvant standard chemotherapy combined with toripalimab, delivered simultaneously with a fasting-mimicking diet intervention.

The Fasting-Mimicking Diet (FMD) will be administered every three weeks for a maximum of 8 consecutive cycles, unless side effects necessitate its temporary or permanent discontinuation. Each FMD cycle will consist of a specific FMD regimen for five consecutive days, repeated every three weeks.

The FMD regimen is a plant-based, low-calorie (approximately 738 kcal on Day 1; approximately 536 kcal on Days 2 to 5), low-protein, low-carbohydrate diet. All patients will follow the identical prescribed FMD regimen. No modifications or personalization to the prescribed FMD plan is permitted. The first FMD cycle will commence two days before the administration of the first cycle of chemoimmunotherapy, be applied on the day of chemotherapy, and continue for two additional days after chemotherapy concludes.

Fasting-mimicking diet

All enrolled patients received standard preoperative chemotherapy combined with anti-PD-1 therapy. The neoadjuvant regimens were guideline-recommended protocols: TP×4-AC×4 combined with PD-1 inhibitor, TP plus PD-1 inhibitor, or PD-1 inhibitor combined with other taxane-based regimens.

* T: Taxanes, including docetaxel, nab-paclitaxel, and paclitaxel.
* P: Platinum agents.
* A: Anthracyclines, including epirubicin, pirarubicin, and doxorubicin.
* C: Cyclophosphamide.

Chemotherapy

In the neoadjuvant phase, toripalimab (anti-PD-1) was dosed intravenously at 240 mg on day 1 of every 21-day cycle.

Toripalimab

Jun Tang, MD

Ning Li, PhD

Single dose of JNT-517 or placebo in fasted state.

JNT-517 Suspension

Placebo Suspension

JNT-517 or placebo once or twice daily for 14 days, with first daily dose given after an overnight fast.

Single dose of JNT-517 suspension, JNT-517 tablet in a fasted state, and JNT-517 tablet in a fed state in a sequential, open-label manner. Each treatment is separated by a minimum of 5 half-lives.

JNT-517 Tablet

Single dose of JNT-517 tablet in a fasted state, JNT-517 tablet in a fed state, and JNT-517 suspension in a sequential, open-label manner. Each treatment is separated by a minimum of 5 half-lives.

Single dose of JNT-517 tablet in a fed state, JNT-517 suspension, and JNT-517 tablet in a fasted state in a sequential, open-label manner. Each treatment is separated by a minimum of 5 half-lives.

JNT-517 or placebo daily for 4 weeks. Dose is based on data from Parts A, B, and C.

Placebo Tablet

Otsuka Pharmaceutical Development & Commercialization, Inc.

Patients receive tazemetostat PO BID on days -1 to 6, and CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients also undergo bone marrow aspiration and biopsy and blood sample collection during screening and on study.

Tazemetostat

Liposome-encapsulated Daunorubicin-Cytarabine

Undergo bone marrow aspiration and biopsy

Bone Marrow Aspiration and Biopsy

Biospecimen Collection

Patients receive palbociclib PO QD on days -3 to -1, then tazemetostat PO twice daily (Days -1 to 6), and CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients also undergo bone marrow aspiration and biopsy and blood sample collection during screening and on study.

Palbociclib

Patients in both the Phase I and Phase II portion of the study will receive lymphodepleting chemotherapy (unless determined by PI that lymphodepletion is not necessary), followed by a single infusion of the patient-derived SJCAR19 cellular product. The most commonly used lymphodepleting chemotherapy regimen will consist of the agents: Fludarabine and Cyclophosphamide. They will also receive Mesna. Dosing of SJCAR19 on the Phase I study will follow a dose escalation schema, with dose changes based on dose-limiting toxicities. In the Phase II study, SJCAR19 dosing with follow the maximum tolerated dose, as determined in the Phase I portion.

Cells for infusion are prepared using the CliniMACS System.

Cyclophosphamide

Fludarabine

Mesna

The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest.

CliniMACS

CD19- specific CAR engineered autologous T-cells (SJCAR19 product)

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<dt>거짓 부갑상선기능저하증 이란?</dt>
<dd>거짓 부갑상선기능저하증은 부갑상선호르몬 수치는 정상이나 호르몬에 대한 부적절한 반응으로 특징되는 유전 질환입니다. 이러한 반응은 뼈 성장에 영향을 미칠 수 있습니다. X-염색체 연관 혹은 상염색체 우성 유전양식으로 유전됩니다.</dd>
<dd> </dd>
<dd><a href="rarenote://MedicalNewsDetail?id=a30039d0-4a44-44da-b6f1-d1a819dc0100">질환에 대해 더 알아보기</a></dd>
</dl>
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네이버 카페

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<dt>알라질 증후군 이란?</dt>
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비정형 용혈요독증후군 환우·보호자들이 모여있는 오픈 채팅방으로 질환 및 치료에 대한 정보를 공유하고, 일상을 공감합니다.

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임상시험 현황

단식 모방 식단, 항암 화학 요법, 토리팔리맙

JNT-517 현탁액, 위약 현탁액, JNT-517 정제, 위약 정제

타제메토스타트, 리포좀 캡슐화 다우노루비신-시타라빈, 골수 흡인 및 생검, 생체 검체 채취, 팔보시클리브

사이클로포스파마이드, 플루다라빈, 메스나, 클리니맥스, CD19 특이적 CAR 엔지니어링 자가 T 세포(SJCAR19 제품)

환자 모임 정보